Apokyn Pregnancy Warnings
Administration of this drug to pregnant rabbits throughout organogenesis was associated with an increased incidence of heart and/or great vessels malformations at mid and high doses tested; maternal toxicity was observed at the highest dose. No adverse developmental effects were observed in rat offspring; maternal toxicity was observed at the highest dose tested (1.5 times maximum recommended human dose). Administration throughout gestation and lactation resulted in increased mortality at the highest dose tested. There are no controlled data in human pregnancy
AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.
US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.
Use is not recommended unless clearly needed
AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned
Risk Summary: There are no adequate data on the developmental risk associated with use in pregnant women; adverse developmental effects have been observed in animal studies.
See references
Apokyn Breastfeeding Warnings
Benefit should outweigh risk
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-There are no data on the effects of this drug on the breastfed infant or its effects on milk production.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects to the breastfed infant from the drug or from the underlying maternal condition.
-Some authorities recommend against breastfeeding while taking this drug due to the possibility of serious adverse reactions to breastfed infant.
See references
